MasterControl is an electronic quality management system (eQMS) that enables life science companies to eliminate paper-based quality processes and observe regulatory standards. With MasterControl, organizations can improve on compliance with FDA regulations and ISO quality standards. They can also increase manufacturing efficiency and product quality.
The web-based solution helps organizations automate GxP processes, and link each stage in a product’s development lifecycle with every department. Automated routing and escalation help ensure quick responses to inputs from departments such as engineering, regulatory, manufacturing, QA, sales and marketing.
MasterControl’s eQMS helps automate and streamline document, change, and training control, as well as corrective/preventive action (CAPA), audits, customer complaints, and other quality and business processes. The solution helps users with automating task assignment, scheduling, tracking, escalation, follow-up and more.
MasterControl Overview
MasterControl Quality Excellence (a QMS Software Solution) is an integrated quality management system that eliminates the need for paper-based quality processes. It helps life-science companies adhere more efficiently to the ever-changing FDA and ISO quality standards.
Its Quality Excellence enables over 1,000 customers across 30 countries to manage their quality and compliance processes and get their products to market at reduced cost with efficiency, regardless of the various regulations they face.
MasterControl QMS also helps you automate task assignment, scheduling, follow-up, tracking, escalation, review, and approval of all document-based processes. The core application in the MasterControl suite integrates all quality processes including change control, customer complaints, corrective/preventive action (CAPA), and audits.
MasterControl also offers a manufacturing solution called MasterControl Manufacturing Excellence. It is a suite of validated solutions that automates the end-to-end production lifecycle. It also integrates seamlessly with other enterprise applications such as MRP, MES, ERP, MOM, and production scheduling.
Training management features include assignment automation and task monitoring, as well as the sequencing of training courses. MasterControl’s nonconformance features help identify, evaluate, review and handle nonconforming materials. Quality audit management helps track basic audit information and findings, and automates the scheduling of recurring audit-related activities.
Users can streamline the complaint-handling process using a multi-page form that customers can access from virtually anywhere.
MasterControl’s Solutions
Paperwork can be overwhelming and costly to your business. It takes up space and consumes resources. MasterControl’s digital documents eliminate those stacks of folders and boxes. It also makes the data sharable and easy to organize and analyze.
Validation Excellence
For many companies, validation is the most excruciating part of regulatory compliance. However, MasterControl’s proven methodology drastically reduces validation time and effort. It offers a full array of validation solutions and services based on regulatory guidance to help maintain a continuous state of compliance.
Exceptional Solutions Fit for Your Needs: The MasterControl Validation Toolkit furnishes all the project and corporate-level templates of validation documentation items and procedures that teams need to fulfill all relevant validation project requirements. It serves as the starting point for validating your MasterControl system and any other software that supports regulated products and services.
Quarterly or Annual Validation Subscription Bundle: MasterControl’s expert consultants are available to guide the entire validation effort. From the risk assessments derived from VxT — including usage testing creation and execution, if recommended by VxT — to a usage testing summary report and a final validation report.
A subscription bundle is available on an annual or quarterly basis. It includes the initial activities necessary to achieve a validated state utilizing VxT and then leverages the VxT change control process to maintain your validated state.
Specialized Validation Services for Clients With Unique Needs: MasterControl offers additional validation services to address integration utilities, custom forms, and data verification qualification. It also provides blocks of time that can be used for validation consultation or guidance.
The MasterControl Platform is the foundation for complete product quality. It connects applications, documentation, and data across the entire product development life cycle, from concept to commercialization.
Document Control
Implementing a digital solution brings automation and streamlines your processes, keeping you effortlessly updated with regulatory changes for easy compliance.
In regulatory environments, effective document control plays a critical role, impacting all quality processes. With MasterControl’s Quality Excellence, a robust quality document control software, you can ensure regulatory compliance with even the strictest regulations and standards while reducing overall costs.
Experience accelerated time to market with our advanced solution.
What Does a Quality Digital Document Control Software Deliver?
Automated Document Control: Simplifies the approval, distribution, retrieval, and obsolescence of documents, and automatically tracks revision history.
Audit Readiness: Maintains all documents in a centralized location that is easily searchable and provides a time-stamped audit trail, reporting, and electronic signatures that are 21 CFR Part 11 compliant.
Streamlined Collaboration: Enables access to necessary documents regardless of geographical location, even for those who are not MasterControl users.
Change Control
Document change control software is essential for ensuring compliance and managing change in regulated industries such as life sciences and manufacturing.
In regulated environments, the term “document change control” encompasses both the document management/control process and the rigorous documentation involved in the change control process. Regardless of the specific context, most companies rely on document change control software to efficiently manage these critical processes.
By implementing document change control software, businesses can track and monitor changes, collect relevant data, and facilitate the approval process. This software provides a centralized platform to ensure all changes are properly controlled and managed throughout the organization, promoting regulatory compliance and mitigating risks. It also lets companies operate in regulated industries and navigate the intricacies of change control. This enables them to adapt swiftly while maintaining compliance with industry regulations and standards.
MasterControl quality and compliance software is a fully integrated web-based solution that provides document change control systems for both document management and change management. It automates and streamlines not only the document control and change control processes, but all other quality processes, including audit management, training control, CAPA, and nonconformance management.
By using MasterControl, companies can effectively address the complexity of change control and streamline their operations.
Training Management
MasterControl’s training management software greatly improves employee training programs. It automates all training tasks, from routing and tracking to follow-up and escalation. Compliance will never be at risk due to a lack of employee training.
Employees need to be informed of training requirements. Then, they report when their training is complete. Manual tracking, follow-up, and escalation processes are slow and prone to error. Training scheduling software resolves these issues by automating all training coordination tasks.
Making sure staff stays up to date with quality process training takes a lot of effort, but it’s essential for compliance. The employee training management system in MasterControl takes care of all training administration tasks. This gives training coordinators more time to focus on creating effective programs that keep employees qualified for their roles.
Audit Management
MasterControl’s audit management software system offers an integrated solution to help companies successfully navigate regulatory audits. By automating tasks and ensuring compliance with a wide range of internal and external standards, this software simplifies the audit planning process and minimizes the time and effort required to pass audits.
In today’s regulatory landscape, companies face various audit requirements. Failing to comply with these standards can be both costly and detrimental to their bottom line. However, with an audit management software system in place, you can confidently face audits with streamlined efficiency.
MasterControl’s audit management software integrates seamlessly with a quality management system (QMS), ensuring accurate and complete documentation throughout the audit process. By automating audit-related tasks, this software reduces the burden on teams, enables effective collaboration, and facilitates the collection of necessary evidence. This comprehensive approach significantly enhances your ability to meet audit requirements and achieve regulatory compliance.
With MasterControl’s audit management software, companies can proactively prepare for audits, maintain audit readiness, and reduce the risk of compliance issues. By optimizing efficiency and accuracy, this software empowers organizations to pass audits successfully, saving both time and resources.
Quality Management
Quality can never be a differentiator if it’s an afterthought or a box to be checked. A complete, end-to-end digital quality management system makes quality at the source possible – and compliance issues a thing of the past.
Thorough and compliant quality management is essential to a regulated company’s continued ability to innovate new products, get to market quickly and sustain growth. But it requires the right systems and tools, and in today’s highly competitive marketplace, paper-based processes no longer suffice.
MasterControl’s digital quality management software (QMS) automates quality throughout the entire product life cycle to help companies navigate ever-changing regulations and standards. It also helps streamline processes, demonstrate compliance, and make quality a true competitive differentiator.
Hundreds of companies around the world use MasterControl’s QMS to automate core business processes and document management activities to promote collaboration, improve decision-making, and accelerate time to market.
CAPA Software
Quality events are inevitable, no matter how much care is taken to avoid them. As a critical part of a quality management system, CAPA identifies and addresses the root causes of high-risk quality issues and helps to limit the resulting business impact, both immediately and in the future.
Improving quality and maintaining compliance depends upon robust CAPA management software. The purpose of CAPA is twofold: to determine why quality events such as nonconformances and deviations have occurred, and to prevent them from happening again. By nature, CAPA processes span various quality systems and the data they produce.
A digital and integrated CAPA solution allows companies to connect key quality channels and downstream processes throughout the entire product life cycle. The result is a streamlined and thorough CAPA management software for better product quality, safety and overall compliance.
Deviations Management
Deviation management is crucial for organizations operating in regulated environments. It helps maintain product quality and aligns with the guidelines set forth by regulatory authorities. When regulated products fail to meet written specifications, it is crucial to document the reasons behind the deviation and conduct a thorough investigation.
MasterControl’s deviation management software provides a streamlined solution for the investigation and resolution of product deviations, resulting in improved quality and simplified regulatory compliance. This solution enables companies to efficiently document, investigate, and resolve deviations, ensuring compliance with regulatory requirements.
Maintaining product quality is paramount in regulated industries, and deviations from approved processes, procedures, instructions, specifications, or established standards can compromise this quality. By utilizing MasterControl’s deviation management software, companies can expedite the identification and resolution of deviations, facilitating prompt corrective actions and minimizing the impact on product quality.
The MasterControl Deviations solution automates the deviation management processes. This eliminates manual paperwork and reduces the time and effort required to document, investigate, and resolve deviations. This software provides a centralized platform for capturing and analyzing deviation data, enabling efficient collaboration and ensuring comprehensive compliance.
With MasterControl’s deviation management software, companies can effectively address deviations, strengthen their quality management processes, and streamline compliance efforts.
Nonconformance Software Systems
The MasterControl nonconformance software system is designed to help companies in ISO and FDA-regulated environments automate paper-based nonconformance processes. It also integrates them with corrective and preventive action (CAPA) processes within the company-wide quality system.
- Increased Efficiency Through Automation: MasterControl automates all tasks pertaining to handling a nonconformance, including notification, follow-up, and escalation of overdue assignments. Automation helps simplify the compliance environment, making it easier to stay compliant.
- Centralized Repository: All documents related to nonconformance will be stored in a secure, centralized repository within the nonconformance software. This makes it easy to search and retrieve them during audits.
- Best-Practice Form: A pre-configured, multi-page form simplifies the process for nonconformance and accelerates the evaluation and disposition of nonconforming materials. It does this by prompting the appropriate departments to collect and track all relevant data. The form is automatically routed through the nonconformance software to responsible personnel and escalates accordingly if the case is not processed promptly.
- Best-Practice Process: This solution incorporates a five-step process that will help the quality unit make timely and appropriate decisions. The process will guide the team from initiation through investigation, recommendation, disposition, and management approval.
- Analytics Reporting Tool: The nonconformance systems include a standard set of pre-configured reports that can be customized by end users. Nonconformances can be trended, and incidents analyzed by material, shift, machine, supplier, etc. These “data-mining” capabilities can give important insight into systemic quality issues and serve as another starting point for CAPA.
- Revision Control: MasterControl provides automatic revision control to ensure that only the current version of a document is available. When a user makes a change in the InfoCard (the MasterControl tool that provides basic information for every record), the user must enter a reason for the change. The nonconformance software tracks all changes made to the InfoCard.
Risk Management
To achieve successful and timely product launches, life sciences companies need to avoid quality risks. This adds costs and causes delays. An automated quality risk management software enables you to quickly identify and mitigate risks in every phase of a product’s life cycle.
MasterControl Risk gives a complete view of the enterprise risk landscape. This includes all product lines, business units, procedures, quality management, document control, and more. The quality risk management software tracking and analysis features let users easily identify and mitigate long-term system, process, and product risks.
MasterControl’s quality risk management software lets you launch risk assessments from anywhere within the MasterControl system. Effectively stay on top of all risks with any process or activity.
Benefits of Using MasterControl
Speed
As a document controller software, MasterControl provides efficiency when it comes to the one-click access to essential documents. As it is cloud-based, all documents can easily be accessed, edited, and routed in just a click regardless if a user is at work or not. Work can be done anytime and anywhere.
Ease of Use
All MasterControl tools are simple and direct. It has a clean and organic dashboard that makes it easy for users to have full control of all necessary document tasks and processes.
Reduced Cost
MasterControl can fully support a paperless operation. Users need not consider huge expenses for paper, printing, and the physical storage of documents. All documents can be digitally saved, stored, routed, and shared with all stakeholders.
Improved Workflow
MasterControl streamlines work by providing solid structuring and standard protocols in the handling, assessing, editing, and sharing of documents. A comprehensive dashboard where documents can be tracked and monitored is provided to all team players and decision-makers.
Convenience
MasterControl is a cloud-based software. Users can easily work on any document or project remotely. No installation is required.
Security
MasterControl is legally compliant. It tends to all legal standards when it comes to document handling and storage. It also encrypts all data in the platform across all endpoints. Users can be secure that all data are safe and protected.
Recommended Articles
- What Is A WLAN: What Is It & Why Do You Need It?
- Cyberduck Competitors: What Are Some Alternatives to Cyberduck?
- Data Profiling: What It Is, Tools & Best Practices
- Top Wonderware Competitors & Alternatives 2023
- Varicent Review: Overview, Features And Alternatives 2023
- WHAT IS OKTA: How Does Okta Work & What You Use It For?
References
- Compare Camp
- MasterControl Official Website
- Software Advice
- GetApp
